BOKANG STETHOSCOPE

Basic Information

• Brand Name: BOKANG STETHOSCOPE
• Primary DI: 06931038630027
• Version / Model: BK3002
• Company Name: WENZHOU BOKANG INSTRUMENTS CO., LTD.
• Labeler DUNS: 421374768
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2018-11-25
• Public Version: 1
• Public Version Date: 2018-12-26
• Public Version Status: New
• Public Device Record Key: b0d322a0-611f-48b1-bef1-8230922e29cc

Device Description

BOKANG STETHOSCOPE is a manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDE	Stethoscope, Manual	Cardiovascular	870.1875	1

GMDN Terms

Code	Name	Definition	Implantable	Status
13755	Mechanical stethoscope	A mechanical listening device designed for listening to sounds from the heart, lungs, and/or gastrointestinal tract. It typically comprises a membrane at the listening head connected by a split "Y" tube to the headgear with ear olives that are placed into the users ears. Mechanical stethoscopes are typically found in two variants 1) a general-purpose stethoscope used for clinical/ward activities; or 2) a reinforced stethoscope used by cardiologists.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06931038630027	GS1